Simulation-based Medical EducationNCT03280199
The Impact of Different Simulator Characteristics on Transfer of Learning
A study testing simulation types in people with Simulation-based Medical Education and Ultrasound Simulation, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
This study aims to explore the impact of different simulator characteristics on transfer of learning. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Simulation-based Medical Education, Ultrasound Simulation, Education, Professional
- What is being tested?
- simulation types
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ISUOG course participants
Who cannot join
- More than 50 independent 2nd trimester US scan before attending the course.
About this study
This study aims to explore the impact of different simulator characteristics on transfer of learning.
Read the detailed description
During an ISUOG basic training course, participants will be randomly assigned to 30 minutes of simulator training during which time they will practice the 2nd trimester US scan. A total of four different simulators are being used for training. After completing the practical basic training session, they shift the type of simulator that they trained on to one of the remaining three simulators. On this simulator, they are required to perform selected planes for the 2nd-trimester scan. The planes produced are recorded and evaluated by fetal medicine specialists using the ISUOG 20 planes checklist. The performances of participants coming from each of the four simulators are examined and the role of 1) type of simulator interaction (physical mannequin vs. virtual abdomen vs. fixed-point scan) and 2) the type of image acquisition (real US images vs. computer-generated images) are examined.
- Being tested
- simulation types
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation typesOther
Different types of simulation interfaces and image acquisitions
| Study group | Role | What they receive |
|---|---|---|
| Type of simulator - 1 | Other | VR simulator with physical mannequin and probe.
PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! Receives: Other: simulation types |
| Type of simulator - 2 | Other | VR simulator with virtual mannequin / abdomen
PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! Receives: Other: simulation types |
| Type of image acquisition - 3 | Other | US images are acquired through real US volumes from patients
PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! Receives: Other: simulation types |
| Type of image acquisition - 4 | Other | US images are acquired through computer-generated images.
PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! Receives: Other: simulation types |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct planes
Number of correct planes produced
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study startSep 2017 (estimated)
- Primary completionSep 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: Was not feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation-based Medical EducationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin G. Tolsgaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280199
- Sponsor's protocol ID
- 2017-09-GCMT
- Status last verified
- Apr 2024
- First submitted
- 10 Sep 2017
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Simulator Characteristics on Transfer of Learning
- ClinicalTrials.gov ID
- NCT03280199
- Acronym / sponsor ID
- 2017-09-GCMT
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Was not feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore the impact of different simulator characteristics on transfer of learning.
Detailed description
During an ISUOG basic training course, participants will be randomly assigned to 30 minutes of simulator training during which time they will practice the 2nd trimester US scan. A total of four different simulators are being used for training. After completing the practical basic training session, they shift the type of simulator that they trained on to one of the remaining three simulators. On this simulator, they are required to perform selected planes for the 2nd-trimester scan. The planes produced are recorded and evaluated by fetal medicine specialists using the ISUOG 20 planes checklist. The performances of participants coming from each of the four simulators are examined and the role of 1) type of simulator interaction (physical mannequin vs. virtual abdomen vs. fixed-point scan) and 2) the type of image acquisition (real US images vs. computer-generated images) are examined.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Type of simulator - 1 | Other | Other: simulation typesVR simulator with physical mannequin and probe. PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! |
| Type of simulator - 2 | Other | Other: simulation typesVR simulator with virtual mannequin / abdomen PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! |
| Type of image acquisition - 3 | Other | Other: simulation typesUS images are acquired through real US volumes from patients PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! |
| Type of image acquisition - 4 | Other | Other: simulation typesUS images are acquired through computer-generated images. PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG! |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ISUOG course participants
Key exclusion criteria (1 listed)
- More than 50 independent 2nd trimester US scan before attending the course.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simulation typesDifferent types of simulation interfaces and image acquisitions | Other | Type of image acquisition - 3, Type of image acquisition - 4, Type of simulator - 1, Type of simulator - 2 |
Primary outcome
Correct planes
Time frame: 30 minutes
Number of correct planes produced
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing simulation types in people with Simulation-based Medical Education and Ultrasound Simulation, run by Copenhagen University Hospital, Rigshospitalet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct planes (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.